# FDA 483 - Gynex Corporation - January 06, 2020

Source: https://www.globalkeysolutions.net/records/483/gynex-corporation/ac29ccfd-7f5c-45d6-ab75-ab6e7677126d

> FDA 483 for Gynex Corporation on January 06, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gynex Corporation
- Inspection Date: 2020-01-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Gynex Corporation, a medical device manufacturer in Redmond, WA, was inspected by the FDA from January 2-6, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, complaint handling, equipment calibration, supplier evaluation, and nonconforming product disposition. The firm failed to adequately establish and follow procedures for these critical areas.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)

Company: https://www.globalkeysolutions.net/companies/gynex-corporation/3320db3d-b0e6-4488-8161-0265bdcd9b4d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822